NCT06430112

Brief Summary

Few studies have compared the efficacy of ultrasound (US)-guided TAP blocks with Liposomal bupivacaine(LB) versus ropivacaine in reducing postoperative opioid usage in patients undergoing laparoscopic lower abdominal tumor Resection. Therefore, we are conducting this prospective, randomized controlled trial to compare the postoperative analgesic effects of LB and ropivacaine for TAP blocks among patients undergoing laparoscopic colorectal procedures.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
74

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Nov 2023

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 20, 2024

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

May 21, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 28, 2024

Completed
4 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2024

Completed
Last Updated

May 28, 2024

Status Verified

May 1, 2024

Enrollment Period

7 months

First QC Date

May 21, 2024

Last Update Submit

May 21, 2024

Conditions

Abdominal TumorPostoperative AnalgesiaLiposomal BupivacaineRopivacaine

Keywords

liposomal bupivacaineropivacainetransversus abdominis plane blocklaparoscopic lower abdominal tumor resectionopioid consumption

Outcome Measures

Primary Outcomes (1)

  • Postoperative opioid use

    The amount of drug used in the postoperative analgesia pump

    3 days postoperatively

Secondary Outcomes (2)

  • Postoperative pain score

    3 days postoperatively

  • Postoperative adverse reactions

    3 days postoperatively

Study Arms (2)

Liposomal Bupivacaine group

EXPERIMENTAL

Liposomal Bupivacaine was used in the group

Drug: Liposomal Bupivacaine

Ropivacaine group

ACTIVE COMPARATOR

Ropivacaine was used in this group

Drug: Ropivacaine

Interventions

Liposomal BupivacaineDRUG

After induction of anesthesia, bilateral TAPB was performed under ultrasound guidance. The patients in the bupivacaine liposome group were injected with bupivacaine liposome 133mg(10ml+ 10ml 0.9% normal saline mixed into 20ml)/ point (two points in total).

Also known as: Bupivacaine liposome
Liposomal Bupivacaine group
RopivacaineDRUG

Patients in ropivacaine group were given 0.25% ropivacaine 20ml/ point (two points in total).

Also known as: Ropivacaine Hydrochloride Injection
Ropivacaine group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients undergoing laparoscopic resection of lower abdominal tumors
  • ASA grade II-III
  • Age: 18-70 years.

You may not qualify if:

  • (1) The patient does not agree to participate in the clinical study
  • (2) The patient has a clear history of opioid tolerance or allergy
  • (3) The patient has a history of local anesthetic allergy
  • (4) Previous history of dementia, mental illness or other central nervous system diseases
  • (5) Have a history of chronic pain or are taking opioids and other analgesics
  • (6) Patients are generally in poor condition with a history of serious diseases of cardiovascular system, respiratory system, digestive system, urinary system or central nervous system, and may not survive for more than 3 months
  • (7) The patient had any of the following conditions in the 12 months before surgery: myocardial infarction, severe/unstable angina pectoris, coronary artery bypass grafting, congestive heart failure, cerebrovascular accident, pulmonary embolism
  • (8) Pregnant women
  • (9) Unable to cooperate with follow-up or poor compliance
  • (10) Patients with acute myocardial infarction, cardiac arrest or shock during surgery or hospitalization
  • (11) ASA score above grade III.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jingdun Xie

Guangzhou, Guangdong, 510060, China

RECRUITING

MeSH Terms

Conditions

Abdominal Neoplasms

Interventions

Ropivacaine

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasms

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Jingdun Xie

    Department of Anesthesiology,Sun Yat-Sen University Cancer Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ping Yu

CONTACT

00-86-13631373286yuping@sysucc.org.cn

Jingdun Xie

CONTACT

00-86-13560380116xiejd@sysucc.org.cn

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

May 21, 2024

First Posted

May 28, 2024

Study Start

November 1, 2023

Primary Completion

May 20, 2024

Study Completion

June 1, 2024

Last Updated

May 28, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will share

https://www.medicalresearch.org.cn/,Time: After completing the academic paper for publication

Shared Documents
STUDY PROTOCOL
Time Frame
After completing the academic paper for publication
Access Criteria
The persons who were willing to study.

Locations

CN(1)